Irb Health Insurance Portability & Accountability Act Compliance Application printable pdf download

Health Insurance Portability & Accountability Act (HIPAA)

Compliance Application

FWA-00003965/IRB-00002563

IRB Office 101 - Altru Psychiatry Center

860 S. Columbia Rd, Grand Forks, North Dakota 58201

Phone: (701) 780-6161

PROJECT TITLE & IRB NUMBER _______________

PRINCIPAL INVESTIGATOR Name (First, Last)

Please complete this form if you intend to use/disclose protected health information (PHI) in your

research. PHI is health information transmitted or maintained in any form or medium that: identifies or could

be used to identify an individual; is created or received by a healthcare provider, health plan, employer, or

healthcare clearinghouse; and relates to the past, present, or future physical or mental health or condition of an

individual; the provision of healthcare to an individual; or the past, present, or future payment for the provision

of healthcare to an individual

An investigator may access PHI using one or more of the following methods. Unless otherwise noted, you

should complete this entire form as applicable.

A. Please check the appropriate box(es) for your specific research.

De-identified Information: De-identified Information is health information that cannot be

linked to an individual. Research which involves the use of “de-identified” PHI is exempt

from HIPAA requirements. The HIPAA Privacy Rule regulations [45 CFR 164.514(b)]

lists 18 specific identifiers that must be removed from the health information before the

researcher obtains the information for it to be considered not identifiable. The list includes:

Name/initials; Street address, city, county, precinct, zip code and equivalent geocodes; All

elements of dates (except year) directly related to an individual (date of birth, admission

date, discharge date, date of death); Elements of date, including year, for persons 90 or

older; Telephone number; Fax number; Electronic mail address; Social Security Number;

Medical record numbers; Health plan identification numbers; Account numbers

Certificate/license numbers; Vehicle identifiers and serial numbers, including license plate

numbers; Device identifiers and serial numbers; Web addresses (URLs); Internet IP

addresses; Biometric identifiers, including finger and voice prints; Full face photographic

images and any comparable images; Any other unique identifying number, characteristic or

code.

If the research does not include access to any of the above identifiers, sign the certification at the

bottom of the page. The HIPAA privacy regulations do not apply and you are not required to

complete the rest of the application.

(Sign and Date this section only if the research involves De-Identified Information)

I certify the PHI received or reviewed by research personnel for the research referenced above

does not include any of the identifiers listed above.

Principal Investigator Signature

Date

Irb Health Insurance Portability & Accountability Act Compliance Application